A total of 90 patients suffering from end stage-IV Fontaine /CLI and diabetic foot with an ulcerated limb in whom all previous therapeutic strategies failed (e.g. surgical revascularization) will be selected and undergo local transplantation of ABMSCs. The efficacy/safety of this therapy will be assessed by using several endpoints such as (a) prevention of amputation, (b) wound healing and (c) degree of angiogenesis. In order to assess the limb ischemia and hypoxia the several tests and measurements will be performed pre- and post transplantation at a variety of time intervals. The measurements include: TP-toe pressure measurements (by Periflux 5000 Laser Doppler and Oxymetry system), SPP-skin perfusion pressure, ABI-ankle brachial index, LDP-laser Doppler baseline and heat perfusion assessment, TcpO2 without and with O2 provocation inhalation test. In addition, a battery of biochemical and hematological tests of peripheral venous blood sample will be performed.The quality form "EQ-50" will be completed.

8.2 Secondary objectives: 8.2.1 To assess effect of ABMSCs on tissue perfusion of ischemic limb after transplantation by transcutaneous oximetry and the laser Doppler flowmetry using Periflux 5000 system under normal and provocation test conditions. In addition, wound healing of ulcers will be evaluated using a planimetry method from photographs of affected skin taken pre- and post-transplantation.

8.3 Priorities: Beside assessment of effectiveness and safety of ABMSCs transplantation ultimate emphasis will be put on avoiding limb amputation. This has significant socioeconomic impact. Therefore this project belongs to the priority programs of clinical research in cardiovascular diseases.

Collection of 240ml from both illiac crests, followed by gradient density centrifugation, resulting in obtaining 40ml of BMAC. This ammount is applied by one ml per injection into the critical limb ischemia along the calf vessels.

Procedure: BMAC application in Critical Limb Ischemia

Collection of 240ml from both illiac crests, followed by gradient density centrifugation, resulting in obtaining 40ml of BMAC (Bone-Marrow Aspiration Concentrate). BMAC is subsequently administered into the ischemic limb along calf vessels.

Other Names:

Critical Limb Ischemia

Bone-Marrow Aspiration Concentrate

Laser Doppler

No Intervention: Control Study Group

Standard treatment group of patients with CLI after surgical or interventional revascularisation will serve as control.

with failed basic conservative and revascularization treatment (surgical or endovascular),

with age over 18 years,

with signed informed consent for this procedure,

without acute CLI that would require early limb amputation.

Exclusion Criteria:

patients with estimated survival less than 6 months,

with known bone marrow diseases,

with the final stage of renal failure and dialysed,

with acute stage of severe limb ischemia with severe inflammatory process affecting patient`s life which require limb amputation to avert deterioration in clinical condition and death.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232673